Carbamazepine
- Product NDC
- 43063-328
- 11-digit product format
- 430630328
- Labeler code
- 43063
- Product ID
- 43063-328_47a67b68-3732-3c2d-e063-6394a90a7788
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA074649
- Marketing category
- ANDA
- Marketing start
- 1996-10-03
- Substance
- CARBAMAZEPINE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Carbamazepine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARBAMAZEPINE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 33CM23913M |
| Rxcui | 308979 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-328-12 | Carbamazepine | 12 in 1 BOTTLE, PLASTIC | TABLET | 12 | | 16 |
| 43063-328-30 | Carbamazepine | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Carbamazepine | ACTIVE INGREDIENT | 33CM23913M | CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| Carbamazepine | ACTIVE MOIETY | 33CM23913M | CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| diethyl phthalate | INACTIVE INGREDIENT | UF064M00AF | CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-328 | CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] | 15 | Current NDC, Legacy NDC, 2 package rows | 20250109_ce5aec7a-e161-46bf-8fc0-afb41689e59a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-328-12 | 43063032812 | 12 TABLET in 1 BOTTLE, PLASTIC (43063-328-12) | 12 tablet | 2011-09-21 | 0000-00-00 | No | No | Current |
| 43063-328-30 | 43063032830 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-328-30) | 30 tablet | 2011-09-21 | 0000-00-00 | No | No | Current |